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  • GSK receives FDA approval for hepatitis B therapy that expands functional cure rates
    GSK announced that the U.S. Food and Drug Administration has granted approval for its hepatitis B drug. The agency said the treatment can achieve functional cures in a larger proportion of patient…
    STAT · 9h agoApprovalPositive↗ source
  • German biotech Immatics eyes pivotal Phase 3 readout after promising uveal melanoma cell therapy results
    Immatics, a German biotech founded 26 years ago, is focusing on cancer immunotherapy. Its lead candidate is an experimental cell therapy targeting uveal melanoma. Early Phase 1 data in 16 patients…
    STAT · 15h agoPositive↗ source
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  • Roivant reports Lisraya beats placebo in Phase 3 trials for non-infectious uveitis
    Roivant and its spinout Priovant announced that Lisraya, an immune-modifying oral drug, showed statistically significant benefit over placebo in two Phase 3 trials for non-infectious uveitis. The…
    STAT · 11h agoPositive readoutPositive↗ source
  • Nigeria confirms travel-linked Ebola case tied to DRC outbreak
    Nigeria's Ministry of Health announced a confirmed Ebola infection in a traveler, marking the country's first case linked to the ongoing outbreak in the Democratic Republic of the Congo. The patie…
    STAT · 11h agoNeutral↗ source
  • Mark Cuban's Cost Plus Drugs targets rare disease market with custom n-of-1 therapies
    Mark Cuban's Cost Plus Drugs, known for low-cost generics, is expanding into rare disease treatments. The company has dedicated part of its new manufacturing plant to producing custom "n-of-1" the…
    STAT · 15h agoPositive↗ source
  • FDA approves Hibsago, first antisense therapy for chronic hepatitis B
    The U.S. Food and Drug Administration has approved Hibsago (bepirovirsen) injection to be used alongside existing antiviral therapy for chronic hepatitis B virus infection in certain adults without…
    fda press · 1d agoApprovalPositive↗ source
  • Massachusetts moves to revoke all RegalCare nursing home licenses after Boston Globe investigation
    Massachusetts regulators announced on Oct 13 that they will revoke every nursing home license held by RegalCare, a New Jersey‑based operator that acquired a dozen facilities in the state after the…
    STAT · 1d agoRegulatoryNegative↗ source
  • Roche signs major partnership with China's Hansoh to co-develop antibody-drug conjugates
    Roche announced a deal with China's Hansoh Pharmaceutical Group to develop a portfolio of antibody-drug conjugates (ADCs). The agreement is described as massive, indicating a significant collabora…
    STAT · 1d agoDealPositive↗ source
  • FDA approves first generic weekly hormone patch for menopausal women
    The U.S. Food and Drug Administration has granted approval for a generic version of a once‑weekly transdermal hormone patch that combines estradiol and levonorgestrel. The product matches the brand…
    fda press · 1d agoApprovalPositive↗ source
  • Dana-Farber and Beth Israel Lahey Health break ground on $1.68 billion cancer hospital in Boston
    Officials from Dana-Farber Cancer Institute and Beth Israel Lahey Health announced the start of construction on a new dedicated cancer hospital in Boston's Longwood area. The project is budgeted at…
    STAT · 1d agoDealPositive↗ source
  • JAMA paper on OpenEvidence highlights clinician use but raises unanswered questions
    A new study published in JAMA examines how clinicians are employing the OpenEvidence platform, an artificial-intelligence-driven tool designed to assist medical decision-making. The authors highli…
    STAT · 1d agoNeutral↗ source
  • FDA Grants Accelerated Approval for Jemperli Immunotherapy in Locally Advanced Rectal Cancer
    The U.S. Food and Drug Administration has granted accelerated approval for a new use of the immunotherapy Jemperli (dostarlimab‑gxly). The approval applies to adults with previously untreated stage…
    fda press · 2d agoApprovalPositive↗ source
  • Gilead’s oral ulcerative colitis drug shows significant remission in Phase 2 trial
    Gilead Sciences reported results from a Phase 2 trial of its oral ulcerative colitis drug emvistegrast. In the study, patients took a 200 mg daily dose for 12 weeks and achieved a 23% placebo-adju…
    STAT · 2d agoPositive readoutPositive↗ source
  • Trump signs executive order to create NIH division and White House task force for women’s health
    President Donald Trump signed an executive order on Monday establishing a new division within the National Institutes of Health and a White House task force focused on women’s health. The order dir…
    STAT · 2d agoRegulatoryNeutral↗ source
  • China proposes new limits on foreign biotech acquisitions to protect domestic drug development
    China is drafting new rules that would restrict foreign companies from acquiring Chinese biotech assets deemed critical to the nation's drug development sector. The proposal aims to keep control o…
    STAT · 2d agoRegulatoryNeutral↗ source
  • Nonprofit arbitrators under No Surprises Act earning large profits, investigation finds
    A recent STAT investigation examined the role of nonprofit organizations that serve as arbitrators under the No Surprises Act. The report found that these entities are generating substantial revenu…
    STAT · 2d agoRegulatoryNegative↗ source
  • Alphabet’s Isomorphic Labs draws VC interest as it seeks to turn AI protein modeling into drug discovery engine
    Isomorphic Labs, an Alphabet spin‑off, is building a platform that uses its protein‑modeling AI to create new medicines. The secretive startup has not been actively raising money, but venture firm…
    STAT · 2d agoNeutral↗ source
  • Immunology Society Split Over California’s $8.4 B Proposition 38 Funding Measure
    Internal emails obtained by STAT reveal a sharp split within the American Association of Immunologists over California’s Proposition 38, a ballot measure that would direct $8.4 billion of taxpayer…
    STAT · 2d agoNeutral↗ source
  • Arbitrators profit heavily from No Surprises Act disputes, raising concerns over health-care billing practices
    The STAT Health Care Inc. newsletter reports that the arbitration mechanism created by the No Surprises Act, intended to resolve out-of-network billing conflicts, has become a lucrative business fo…
    STAT · 2d agoNegative↗ source
  • Theranos whistleblower says new film ‘You Can See Everything’ is art, not a documentary
    Tyler Shultz, a former Theranos scientist who became a whistleblower, wrote an opinion piece criticizing Nathan Fielder’s recent film about Elizabeth Holmes. He argues the movie, titled “You Can S…
    STAT · 2d agoNegative↗ source
  • Cambridge biologist David Sabatini awarded $6 million after jury rejects harassment claims
    David Sabatini, a former MIT and Whitehead Institute researcher, faced allegations of inappropriate conduct from a younger colleague, leading to his removal from the institute. A Suffolk County ju…
    STAT · 2d agoPositive↗ source
  • Jury awards $6 million to former MIT professor David Sabatini in defamation case
    A Suffolk County jury awarded $6 million in damages to former MIT professor David Sabatini after finding the plaintiff's claims were defamatory. The case stemmed from accusations by a younger coll…
    STAT · 4d agoPositive↗ source
  • Revolution Medicines' pancreatic cancer therapy Rasonque moves closer to European approval after FDA clearance
    Revolution Medicines' experimental drug Rasonque, aimed at treating pancreatic cancer, has received a recommendation for approval from European regulators. The recommendation follows an earlier po…
    STAT · 5d agoApprovalPositive↗ source
  • Key reads to catch up on Elizabeth Holmes before the new documentary releases
    STAT’s Morning Rounds newsletter offers a curated list of articles to review before watching the documentary "You Can See Everything" about Elizabeth Holmes. The piece reminds readers of the major…
    STAT · 5d agoNeutral↗ source
  • Jury deliberates conflicting accounts in David Sabatini misconduct trial at Whitehead Institute
    A Boston jury is hearing a civil case that pits two very different narratives about the conduct of renowned molecular biologist David Sabatini. The three‑week trial has focused on accusations that…
    STAT · 5d agoNegative↗ source